Healthy
Conditions
Keywords
CT scan, oral contrast
Brief summary
Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
Detailed description
Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered. Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows: Omnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine) The time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed. After completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows: * 2=Dislike very much * 1=Dislike moderately 0=Neither like nor dislike * 1=Like moderately * 2=Like very much A taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data. Planned rating scale is as follows: * 1- A is better 0 -no difference * 1- B is better Patients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following. Bowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows: 0= absent opacification 1. minimal (\<25% of analyzed segments opacified) 2. good (\>25 % and \< 75% of analyzed segments opacified) 3. excellent (\> 75% of analyzed segments opacified) Description of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.
Interventions
DRUGOmnipaque
Oral CT contrast
DRUGGastroview
Oral CT contrast
Sponsors
GE Healthcare
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.
Exclusion criteria
* Not competent to give consent. * Pregnant. * Known allergy to either of the contrast agents. * Loss of sense of taste or smell. * Contraindication to oral administration such as aspiration risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred Contrast Agent | 1 Day | The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Opacification Score | Collected day of study | The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score. |
Countries
United States
Participant flow
Recruitment details
Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration.
Participants by arm
| Arm | Count |
|---|---|
| Gastroview Oral Gastroview prior to CT | 151 |
| Omnipaque Oral Omnipaque prior to CT | 149 |
| Total | 300 |
Baseline characteristics
| Characteristic | Omnipaque | Gastroview | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 40 Participants | 93 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 111 Participants | 207 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 15 | 56 years STANDARD_DEVIATION 15 | 57 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 149 participants | 151 participants | 300 participants |
| Sex: Female, Male Female | 56 Participants | 60 Participants | 116 Participants |
| Sex: Female, Male Male | 93 Participants | 91 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 151 | 0 / 149 |
| serious Total, serious adverse events | 0 / 151 | 0 / 149 |
Outcome results
Primary
Preferred Contrast Agent
The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.
Time frame: 1 Day
Population: Analysis was per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gastroview | Preferred Contrast Agent | Prefer Gastroview | 25 participants |
| Gastroview | Preferred Contrast Agent | Prefer Omnipaque | 117 participants |
| Gastroview | Preferred Contrast Agent | No Preference | 9 participants |
| Omnipaque | Preferred Contrast Agent | Prefer Gastroview | 29 participants |
| Omnipaque | Preferred Contrast Agent | Prefer Omnipaque | 116 participants |
| Omnipaque | Preferred Contrast Agent | No Preference | 4 participants |
Comparison: All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.p-value: <0.001Binomial test of proportion
Secondary
Bowel Opacification Score
The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.
Time frame: Collected day of study
Population: per protocol - all patients had usable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastroview | Bowel Opacification Score | 8.57 units on a scale | Standard Deviation 1.96 |
| Omnipaque | Bowel Opacification Score | 8.85 units on a scale | Standard Deviation 1.71 |
Comparison: Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.p-value: 0.27Wilcoxon (Mann-Whitney)